Adverse Events

Investigators are required to report to the WVDE IRB any adverse events that result in unanticipated problems during the course of their research. Guidance from OHRP defines an unanticipated problem as any incident, experience or outcome that meets all of the following criteria:

  1. is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
  2. related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Investigators are responsible for reporting all adverse events that result in unanticipated problems immediately. The principal investigator must notify the IRB within 24 hours and then complete an IRB Adverse Event Reporting Form and submit it directly to the IRB Secretary and Chair for documentation.

The IRB Adverse Event Reporting Form requires a detailed description of the event, incident, experience, or outcome, an explanation of the basis for determining that the event, incident, experience, or outcome represents an unanticipated problem, and a description of any changes to the protocol or other corrective actions that have been taken or are proposed in response to the unanticipated problem. The IRB also requires the principal investigator to submit any supporting documentation which illustrates the changes that have taken place (e.g., sample consent forms/data collection instruments).

Forms Required for Reporting an Adverse Event Resulting in an Unanticipated Problem
Form Notes
IRB Adverse Event Reporting Form Must be submitted within 24 hours of the event's occurrence
Supporting Documentation e.g., revised consent forms, data collection instruments, etc.

Important Information for WVDE Employees

There are serious consequences for not reporting adverse events in a timely manner. Always report these events immediately.